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Outcome Evaluation for Burn Scar Therapy-laser and Surgery in Patients in Formosa Fun Coast Explosion

Primary Purpose

Patients With Major Burn Injury in Formosa FunCost Explosion

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laser and Surgery
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patients With Major Burn Injury in Formosa FunCost Explosion focused on measuring burn scar, laser, ultrapulse

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. >20% major burn scar, for 3 years
  2. patients in Formosa FunCost Explosion
  3. offering medical records, including laser and treatments
  4. available for questionnaire evaluation and others' evaluation
  5. those are willing to receive both sonography on scars and HRV evaluation

Exclusion Criteria:

  1. those aren't willing to offer medical records
  2. those aren't willing to fill questionnaire
  3. those aren't willing to receive sonography on scars

Sites / Locations

  • Shin Kong Wu Ho Su Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Laser and Surgery in patients with major burn scars

Arm Description

Evaluating patients with major burn scar after laser and surgical treatments Multiple-directions evaluation, including senior plastic resident, young resident, professional burn surgeons, senior nurse with burn scar, one non-medical patients(usually patients' family and friends)

Outcomes

Primary Outcome Measures

Patients objective questionnaire
Patients objective questionnaires is used to evaluate subjects' sensation and life quality, in which pain, itchiness and sleep are evaluated by Visual Analogue Scale (VAS), Burn Itchiness Scale and Sleep Assessment Scale, respectively.
Burn assessment by researchers
Burn scars are assessed using Vancouver scar scale by four plastic surgeons and a non-professional person.

Secondary Outcome Measures

Scar evaluation by sonography (selective)
Burn scars in lower extremity are measured using 2-D problem sonography machine.
Autonomic nervous system analysis (selective)
Autonomic nervous system analysis is performed by heart-rate variability machine (HRV MACHINE).

Full Information

First Posted
November 28, 2018
Last Updated
April 18, 2019
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03922399
Brief Title
Outcome Evaluation for Burn Scar Therapy-laser and Surgery in Patients in Formosa Fun Coast Explosion
Official Title
Outcome Evaluation for Burn Scar Therapy-laser and Surgery in Patients in Formosa Fun Coast Explosion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
January 27, 2019 (Actual)
Study Completion Date
March 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Protocol title： Outcome evaluation for burn scar therapy-laser and surgery in patients in Formosa Fun Coast Explosion Objectives： The goal of this study is to evaluate the effectiveness of both lasers and operations on patients with major burn scar(>20% TBSA).
Detailed Description
Background： There is no gold standard treatment for burn scar treatment, especially for those with major burn scar. In the Formosa Fun-Coast Dust Explosion in 2015, lots of patients with major burn scar suffer from severe pathologic burn scar syndromes. The gold of the study is to evaluate the efficacy of both lasers and operations on major burn scars treatment in the past two years. Study Design： To take the assessment of scar into account, the investigators use both objectives and subjective methods to evaluate the scar condition. In addition to the scale of scar, the investigators also use both sonography and HRV system to evaluate the expressions of scar. All evaluated tools used are the same as those used in 20160201R and 20160202R. The investigators also used previous records to check the patient's scar condition before these treatments. Hypothesis： After treatment, scar conditions should get better than before. However, the investigators need more scientific statistics to evaluate the improve rate. Key words： Burn scar, burn scar syndromes. Scar laser treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Major Burn Injury in Formosa FunCost Explosion
Keywords
burn scar, laser, ultrapulse

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with major burn scar, after lasers treatment for three years Evaluation tool: questionnaires, sonography, HRV
Masking
None (Open Label)
Masking Description
evaluating in different medical groups
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser and Surgery in patients with major burn scars
Arm Type
Other
Arm Description
Evaluating patients with major burn scar after laser and surgical treatments Multiple-directions evaluation, including senior plastic resident, young resident, professional burn surgeons, senior nurse with burn scar, one non-medical patients(usually patients' family and friends)
Intervention Type
Procedure
Intervention Name(s)
Laser and Surgery
Intervention Description
Laser and Surgery in patients with major burn scars Evaluating after three years treatment
Primary Outcome Measure Information:
Title
Patients objective questionnaire
Description
Patients objective questionnaires is used to evaluate subjects' sensation and life quality, in which pain, itchiness and sleep are evaluated by Visual Analogue Scale (VAS), Burn Itchiness Scale and Sleep Assessment Scale, respectively.
Time Frame
Week 0
Title
Burn assessment by researchers
Description
Burn scars are assessed using Vancouver scar scale by four plastic surgeons and a non-professional person.
Time Frame
Week 0
Secondary Outcome Measure Information:
Title
Scar evaluation by sonography (selective)
Description
Burn scars in lower extremity are measured using 2-D problem sonography machine.
Time Frame
Week 0
Title
Autonomic nervous system analysis (selective)
Description
Autonomic nervous system analysis is performed by heart-rate variability machine (HRV MACHINE).
Time Frame
Week 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >20% major burn scar, for 3 years patients in Formosa FunCost Explosion offering medical records, including laser and treatments available for questionnaire evaluation and others' evaluation those are willing to receive both sonography on scars and HRV evaluation Exclusion Criteria: those aren't willing to offer medical records those aren't willing to fill questionnaire those aren't willing to receive sonography on scars
Facility Information:
Facility Name
Shin Kong Wu Ho Su Memorial Hospital
City
Taipei
ZIP/Postal Code
11101
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
lasers treatments, especially patients with major burn cases, are widely used. Therefore, we still consider the results after three years' treatments.

Learn more about this trial

Outcome Evaluation for Burn Scar Therapy-laser and Surgery in Patients in Formosa Fun Coast Explosion

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